NCT03684057

Targeting Worry to Improve Sleep

Completed NA Results posted Last updated 10 October 2022

What this trial tests

NA trial testing App-Delivered Mindfulness Training (MT) in Anxiety in 80 participants. Completed in 26 February 2020.

Timeline

25 July 2019

Primary endpoint
26 February 2020

26 February 2020

Quick facts

Lead sponsor	Brown University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	80
Start date	25 July 2019
Primary completion	26 February 2020
Estimated completion	26 February 2020
Sites	1 location across United States

Drugs / interventions tested

• App-Delivered Mindfulness Training (MT)

Conditions studied

• Anxiety — all drugs for Anxiety →
• Sleep Disturbance — all drugs for Sleep Disturbance →

Sponsor

Brown University

Who can join

18 and older, any sex, with Anxiety or Sleep Disturbance. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Worry-related Sleep Disturbances Primary · Baseline, 2 months

5 questions from the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29) pertaining to anxiety and sleep will be used to assess worry-related sleep disturbances over the past 7 days. These questions are on a 5-point Likert scale where 1 is "Not at all" and 5 is "Very much". Scores can range from 5 to 25 and higher scores indicate a worse outcome.

Group	Value	95% CI
TAU + App-Delivered Mindfulness Training (MT)	-4	-8.0 – -2.8
Treatment as Usual (TAU)	-1	-4 – 2.0

Change in Worry Secondary · Baseline, 2 months

Penn State Worry Questionnaire (PSWQ) will be used to assess worry. The PSWQ is a 16-item questionnaire that uses a 5-point Likert scale where 1 is "Not at all typical of me" and 5 is "Very typical of me". Scores can range from 16 to 80 and higher scores indicate a worse outcome

Group	Value	95% CI
TAU and App-delivered Mindfulness Training (MT)	-9	-12.2 – -1.0
Treatment as Usual (TAU)	0.0	-4.0 – 2.5

Change in Total Sleep Time (TST) Secondary · Baseline, 2 months

A Fitbit will be used to assess sleep trends over a 1 week period

Group	Value	95% CI
TAU and App-delivered Mindfulness Training (MT)	9	-28 – 34
Treatment as Usual (TAU)	3	-21 – 37

Changes in Non-reactivity Secondary · Baseline, 2 months

Non-reactivity subscale from the 15-item Five Facet Mindfulness Questionnaire (FFMQ) will be used to measure changes in emotional reactivity. This subscale is based on responses to 3 questions measured on a 5-point Likert scale where 1 is "Never or rarely" and 5 is "Very often or always true". Scores can range from 3 to 15 and higher scores indicate a better outcome.

Group	Value	95% CI
TAU + App-Delivered Mindfulness Training (MT)	4.5	1.0 – 6.0
Treatment as Usual (TAU)	0	-2.0 – 2.5

Sponsor's own description

The purpose of this study is to test an app-based mindfulness training program for worry to see if it can help individuals decrease worry and improve sleep.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Targeting Anxiety to Improve Sleep Disturbance: A Randomized Clinical Trial of App-Based Mindfulness Training.
   Gao M, Roy A, Deluty A, Sharkey KM, et al · · 2022 · cited 16× · PMID 35420589 · DOI 10.1097/psy.0000000000001083